An investigation was performed on returned product and it was found that the location of the damage was consistent with the location of the manifold and reservoir components found in this kit.It was also found that these components were dislodged and packaging welds used to secure these components were broken.In order to further determine if this damage was caused prior to shipping, the remaining units in stock were inspected and no damage was found.Based on the results of the investigation and the description of the damage, it was determined that these issues were caused by rough handling of the device during shipping.In order to provide better protection and prevent future issues, an agreement was made with the customer, which will facilitate the shipment of multiple units in palletized form.Additionally, shipments will be labeled as "fragile life support device", prior to shipping to ensure they are handled in the correct manner.(b)(4).
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